Application 078692

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	5MG	No	No
002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	10MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL			2008-02-14
A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL		RS	2008-02-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078692-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL		2008-02-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078692-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	RS	2008-02-14	`bb7c543d1eb4…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sandoz Inc	a814a06b-96ed-4403-bbd7-fc1142988b50	2025-06-30	Warnings	Exact identifier application applno (ANDA): 078692 application number: ANDA078692 ndc (product): 0781-5284
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Sandoz Inc	817d07cf-5e31-421f-9e95-943bae01f5b0	2025-06-30	Warnings	Exact identifier application applno (ANDA): 078692 application number: ANDA078692 ndc (product): 0781-5283

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-5283	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Sandoz Inc	ANDA	Current
0781-5283	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Sandoz Inc	ANDA	Current
0781-5284	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Sandoz Inc	ANDA	Current
0781-5284	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Sandoz Inc	ANDA	Current
0904-5879	Cetirizine Hydrochloride	Cetirizine Hydrochloride	Major Pharmaceuticals	ANDA	Current
11822-0578	Childrens Allergy Relief	Cetirizine HCl	Rite Aid Corporation	ANDA	Current
49035-578	Childrens Allergy Relief	Cetirizine HCl	Wal-Mart Stores Inc	ANDA	Current
50844-578	Childrens Allergy Relief	Cetirizine HCl	L.N.K. International, Inc.	ANDA	Current
50844-578	Childrens Allergy Relief	Cetirizine HCl	L.N.K. International, Inc.	ANDA	Current
50844-578	Childrens Allergy Relief	Cetirizine HCl	L.N.K. International, Inc.	ANDA	Current
59779-978	Allergy Relief	Cetirizine HCl	CVS Pharmacy	ANDA	Current